Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies (COTTONWOOD)

Roche

Status and phase: Terminated; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Etrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02118584

GA28951

2013-004435-72 (EudraCT Number)

Details and patient eligibility

About

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.

Enrollment: 1,822 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Part 1 (Open-label Extension)

• Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol

Part 2 (Safety Monitoring)

• Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
• Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
• Participants who transfer from Part 1 (OLE)
• Completion of the 12-week safety follow-up prior to entering.

Exclusion criteria

Part 1 (Open-label Extension)

• Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
• Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
• Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
• Any new, significant, uncontrolled condition

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,822 participants in 2 patient groups

Part 1: Open-label Extension

Experimental group

Description:

Participants with moderate to severe UC who were enrolled in the Phase II OLE study or the Phase III studies, and who meet the eligibility criteria for enrollment will receive open-label etrolizumab in Part 1 (OLE).

Treatment:

Drug: Etrolizumab

Part 2: Safety Monitoring

No Intervention group

Description:

All participants from Part 1 (OLE), participants whose PML follow-up is not completed within the Phase II OLE study, and participants transferring from the Phase III double-blind studies after the 12-week safety follow-up will be monitored for PML (92 weeks).